To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors

Solid Tumors Clinical Trial

Official title:

An Open-Label Study to Determine the Maximum Tolerated Dose of Oral CEP-37440 Administered as a Single Agent in Patients With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922752
• Other study ID #: C37440/1108
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to determine the maximum tolerated dose (MTD), safety, and tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy.
• Patients must have evidence of recurrent, locally advanced, or metastatic disease.
• Patients can either have had no prior anticancer therapy, multiple lines of either prior chemotherapy/biologic therapy/experimental therapy or, if the patient has anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior crizotinib.
• Patients must have a predicted life expectancy of more than 3 months.
• Patients must have presence of at least 1 lesion that is measurable or evaluable using RECIST v1.1.
• Patients must have an ECOG performance score of 0, 1, or 2.
• Patients with central nervous system (CNS) metastases will be allowed on this study. Patients may have received surgical and/or radiation treatment. The metastases must be neurologically stable, on or off corticosteroids. Patients can have low level, asymptomatic brain lesions that do not require surgical/radiation intervention acutely. Patients with symptomatic lesions with impending neurologic compromise should be appropriately treated with high dose steroids/radiation and may be re-evaluated for this study when neurologically stable.
• Patients must have completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy and at least 2 to 3 weeks for all other modalities of therapy including chemotherapy, monoclonal antibody therapy, immunotherapy, other investigational drugs, or other kinase inhibitors.
• Other criteria apply.

Exclusion Criteria:

• The patient has ongoing or active infection requiring parenteral antibiotics.
• The patient has uncontrolled hypertension despite adequate therapy (ie, systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
• The patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
• The patient has an active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers for which they are treated with curative intent, and no known active disease in the 3 years prior to enrollment.
• The patient has a primary brain tumor. Patients may have brain metastases from another primary site.
• The patient has QTcF interval greater than 450 msec, has a known history of QTcF prolongation, is taking medications known to prolong QTcF, or has a history of torsade de pointes.
• The patient has a prior ALK-inhibitor-related toxicity or any other prior therapy-related acute toxicity that has not resolved prior to the first dose of study drug.
• Other criteria apply.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• CEP-37440
CEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily. Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined.

Locations

Country	Name	City	State
United States	Teva Investigational Site 10689	Chicago	Illinois
United States	Teva Investigational Site 10687	Philadelphia	Pennsylvania
United States	Teva Investigational Site 10686	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Evaluation Criteria in Solid Tumors (RECIST v1.1)		8 months
Secondary	Time to Response (TTR)	The time interval from the date of first dose to the first documented response (complete or partial response)	8 months
Secondary	Number of participants with adverse events		From signing of the informed consent to the end of the follow-up visit (approximately Month 10)
Secondary	Time to Progression (TTP)	The time interval from date of first dose to first documented disease progression	8 months
Secondary	Progression-free Survival (PFS)	Time interval from date of first does to first documented disease progression or death from any cause (whichever occurs first)	10 months
Secondary	Time to New Metastases (TTNM)	Time interval from date of first dose to first documented new metastatic lesion not reported at baseline	8 months